1. Field of the Invention
The invention relates to novel probes designed for use with an electrical current therapy device to treat hemorrhoids.
2. Description of the Prior Art
Hemorrhoidal disease is one of the most frequent, disabling, and painful conditions of mankind. The consensus of the Advisory Panel of the U.S. Food and Drug Administration defines hemorrhoids as “abnormally large or symptomatic conglomerates of blood vessels, supporting tissues, and overlying mucous membrane or skin of the anorectal area.”
It is estimated that one-third of the U.S. population has symptomatic internal hemorrhoids, with an incidence of 50% at age 50 years. Patients frequently postpone examination because of concern of pain associated with a particular treatment modality, hospitalization, cost, and time of disability. Such a delay in evaluation may lead to progression of the hemorrhoidal disease, or late diagnosis of more serious colorectal problems.
Medical procedures for hemorrhoidal treatment have taken many forms. For example, D.C. (direct current) management of hemorrhoidal disease was described in a review published by Wilbur E. Keesey, M. D. in 1934. The topical suppository approach is presently applied to a majority of patients, particularly those with a specific precipitating factor for hemorrhoidal disease (e.g., acute diarrhea episode) and in some instances may be all that is necessary. Necrosis and slough of hemorrhoidal vessels can also, at times, be accomplished by placement of rubber bands over the vessel base with a specific apparatus. This treatment is applicable to those vessels well above the pectinate line to avoid severe pain (a complication in 6 to 10% of patients). Mild to moderately diseased hemorrhoidal vessels are not amenable to this therapy. Injection sclerotherapy is effective for small (grade 1 and 2) bleeding internal hemorrhoids. Submucosal injection of sclerosant produces chemical thrombosis and fixation of the mucosa to the underlying tissue. Sclerotherapy of hemorrhoids is limited to mild to moderate disease and is associated with complications including reaction to the injected material, slough of the overlying mucosa, necrosis, and infection, including submucosal abcess. Cyrosurgery (i.e., application of a metal probe cooled by liquid nitrogen or carbon dioxide) freezes hemorrhoids. Occasionally, local anesthesia is required because of pain. Complications may include imprecise control of the depth of tissue destruction, post-operative pain, and rectal drainage. Surgical excision of hemorrhoidal inflammatory disease has the advantage of removing all associated redundant tissue, including the external component of a particular internal hemorrhoid. However, there are limitations to the amount of excision possible without major adverse sequelae. In a typical patient with many involved vessels, surgery can only approach the most symptomatic-diseased area and is not to be considered curative. The disadvantages of these approaches include pain, expense associated with hospitalization, time of disability, and potential complications, e.g., those associated with anesthesia, surgery proper, and post operative complications, including anal stenosis.
The treatment and correction of hemorrhoids may deploy one or more electrodes for providing radio frequency (RF) energy, microwave energy, or thermal energy to shrink a dilated vein in order to change the fluid flow dynamics and to restore the competency of the venous valve and the proper function of the vein. See U.S. Pat. No. 4,898,169 ('169 Patent).
Incompetent valves in the venous system can occur with vein dilation. Separation of the cusps of the venous valve at the commissure may occur as a result thereby leading to incompetence. Another cause of valvular incompetence occurs when the leaflets are loose and elongated. Loose leaflets of the venous valve results in redundancy, which allows the leaflets to fold on themselves and leave the valve open. These loose leaflets may prolapse, resulting in reflux of blood in the vein. When the venous valve fails, there is an increased strain and pressure on the lower venous sections and overlying tissues sometimes leading to additional valvular failure.
Advancements in the art have been made to treat and cure hemorrhoidal lesions. The method disclosed in the '169 Patent is particularly effective, painless and safe, when used properly. The probes disclosed in the '169 Patent are intended for single use only, and are clearly marked as such. However, the inventors have noted that some physicians attempt to sterilize and reuse the probes. Reuse of the probes in this way is not advisable, since it may increase the risk of generating nosocomial infections in the patient. Proper disposal of used probes are vital to ensuring the safety of patients.